September 30, 2008: JKS News: The Japan Public Health Center-based Prospective Study Group, National Cancer Center   found in 80,000 subjects cohort study published in "American Journal of Epidemiology"
  that increased total daily physical activity is beneficial in cancer prevention ...
Epidemiology consulting and data
September 29-30, 2008: JKS News: Kitasato University   and Harvard School of Public Health   jointly organized their 8th Symposium on "Advanced and Global Drug Development Techniques: Learning from Experience and New Challenges for the Future"
September 29, 2008: JKS News: Two group companies of Mitsubishi Chemical Holdings KK - Tanabe-Mitsubishi Seiyaku KK   and Benesis KK   settled the
long-standing tainted blood products lawsuit, TM President Natsuki Hayama   sealed the compensation agreement, apologized to the sufferers ...
TM product details in JAD Databases |
Hepatitis C related resources | Epidemiology consulting and data
September 25, 2008: PMDA: Pharmaceuticals and Medical Devices Safety Information Bulletin No. 250   released, package inserts of 22 interferon products found to case fatal interstitial pneumonia in Hepatitis C patients revised ... Interferons in JAD Databases | Interferon reports
September 24, 2008: JKS News: The new Japanese Prime Minister   lines up new Cabinet, Health, Labor and Welfare Minister Yoichi Masuzoe
  re-appointed, leadership of Pharmaceutical and Food Safety Bureau (PFSB)   and PMDA
  unchanged ...free resources
September 23, 2008: JKS News: Teva Pharmaceuticals KK   - a subsidiary of Teva Pharmaceutical Industries Ltd. and the unlisted Kowa KK   - a diversified business group, active in both R&D and OTC pharmaceuticals, to form a joint venture company - tentatively named Teva-Kowa Pharma KK for a full scale sale of generics from 2010 ... Teva Master Files and Kowa products in JAD Databases | Generics report preview
September 18, 2008: JKS News: Mid-sized OTC and generics maker Mikasa Seiyaku KK   to be de-listed from Jasdag Stock Exchange   after MBO ...
Mikasa products in JAD Databases |
market consulting |
related reading
September 18, 2008: JKS News: Movements on Medical Representative (MR) scene: Banyu Seiyaku KK   to scale down by 70% its sales locations; Mylan KK   to increase the sales force to 300 MRs; the Japan Pharmaceutical Industry Legal Affairs Association (Ihouken)   proposed a revision of the working contracts for MR for improving relations with project managers ... Approved products in JAD Databases
September 16, 2008: JKS News: The Center for Drug Evaluation and Research, FDA   issues 2 Warning Letters to Ranbaxy Laboratories   and an Import Alert for drugs from two Ranbaxy plants in India: the actions affect over 30 different generic drugs, cites serious manufacturing deficiencies; shares of Daiichi-Sankyo KK   unchanged in Tokyo ... Daiichi Sankyo products in JAD Databases
September 15, 2008: JKS News: On the occasion of "Respect for the Aged Day" the MHLW announced that the number of centenaries exceeds 36,000 and it is expected to reach 1 million in foreseeable future ... Demographics consulting
September 12, 2008: JKS News: The Committee of Drugs of PAFSC, MHLW approved the orphan drug designation for Sodium phenylbutyrate of Ucyclyd Pharma (Medicis Corp.)   and for GlaxoSmithKline Japan KK   pre-pandemic anti-H5N1 vaccine (GSK1557484A) ... Orphan and GSK products in JAD Databases | Vaccine report preview
September 12, 2008: JKS News: Two food companies with pharma operations - Meiji Seika Kaisha KK   and Meiji Nyugyo KK   to merge under Meiji Holding, existing Solvay Meiji Yakuhin KK and Hepatitis B vaccine production to be preserved, new focus on healthy food ... Meiji products in JAD Databases | market consulting | related reading
September 12, 2008: JKS News: Pharmaceutical and Food Safety Bureau (PFSB) update the list of approved FOSHU (food for specified health uses) products - now reaching 1,032 ... Affiliated research site
September 11, 2008: Fuji Keizai KK
  2008 Economic Survey: with introduction in 2008 of the mandatory insurance check-up the market for metabolic syndrome increased by 18.7% and already reached 1.6 trillion Yen ...
report preview
September 10, 2007: JKS News: National Institute of Infectious Diseases (NIID)   unveiled that national measles vaccination level of pubescent population remains under 40% ...
Vaccines in JAD Databases | Vaccine report preview
September 8, 2008: JKS News: Team led by Dr. I. Tsuji
  from the Division of Epidemiology, Department of Public Health & Forensic Medicine, Tohoku University Graduate School of Medicine, found in the Ohsaki Cohort Study published in "Psychosomatic Medicine" journal August 2008 issue
  that lack of "something to live for" (ikigai in Japanese) shortens life expectation ...full news |
Epidemiology consulting and data
September 5, 2008: JKS News: A MHLW Study Group on Safety Issues
proposed an enhanced management safety system in adverse events monitoring for the recommended for approval by the First Subcommittee of Drugs Thalidomide submitted by Fujimoto Seiyaku KK   for treatment of multiple myeloma ... Submitted products in JAD Databases
September 1, 2008: JKS News: Shionogi Seiyaku KK
  acquires 900-employee specialty drugs Sciele Pharma Inc.   to expand the sales network in North American market ...
Shionogi products in JAD Databases |
market consulting |
related reading
August 29, 2008: JKS News: The First Subcommittee of Drugs of PAFSC, MHLW
recommended for approval Pirfenidone developed by Intermune and submitted by Shionogi Seiyaku KK
  as the first treatment for idiopathic pulmonary fibrosis ... Submitted products in JAD Databases
August 28, 2008: JKS News: The Second Subcommittee of Drugs of PAFSC, MHLW
pre-approved orphan drug designation for GlaxoSmithKline Japan KK
pre-pandemic anti-H5N1 vaccine (GSK1557484A), domestic Phase II trial scheduled ... Orphan and GSK products in JAD Databases | Vaccine report preview
August 25, 2008: JKS News: PMDA
released the updated Japan Drug Master Files listing of over 2,200 entries ... JMF details in JAD Databases | Key report reading
August 22, 2008: JKS News: IHI Plant Engineering KK
  reported a purchase of 2% stock of UMN Pharma KK (Unmet Medical Needs Pharma)
  developing anti-H5N1 recombinant influenza vaccine ...
Vaccine details in JAD Databases | Key report preview |
Vaccine consulting
August 20, 2008: JKS News: Yakult Honsha KK
  acquired from USA-based Celsion Corp.   development rights in Japan for ThermoDox, a liposome-encapsulated doxorubicin ... Yakult Honsha anti-cancers in JAD Databases |
Anti-cancers in Japan reports | Unapproved drugs report preview
August 19, 2008: Nihon Keizai Shimbun
  ranks Dainippon Sumitomo Seiyaku KK
  as the 7th among listed Japanese companies in term of capital spending and highest for pharma stock Dainippon Sumitomo products in JAD Databases
August 18, 2008: JKS News: Singapore Prime Minister Lee Hsien Loong
 
declared that "Luring foreign talent gives Singapore edge over Japan", by implication in pharma and healthcare as well
August 13, 2008: JKS News: The Japan Productivity Center for Socio-Economic Development (JPC-SED)   published results from 4th "Approach to Mental Health" corporate survey: 56.1% of responders admit an increase of mental disorders among employees ... Consulting services | Psychiatry report preview
August 12, 2008: JKS News: The Federation of Japan Pharmaceutical Wholesalers Associations (JPWA)
  announced the results for FY 2007 with 0.2% decrease of gross profit and no change in operating profit ... Consulting services | Pricing & Reimbursement in Japan report preview
August 11, 2008: JKS News: Daiichi-Sankyo KK
launches open offer to the public shareholders of Ranbaxy Laboratories Ltd (RLL)
in effort to gain at least 50.1% of the stock ... Daiichi Sankyo products in JAD Databases | report preview
August 8, 2007: Pharmaceutical and Food Safety Bureau (PFSB)
revised
counter indications for Interferon products (Pegasus) in treatment of HBV and HCV infections; added
safety precautions for antihypertensive drugs ... relevant products in JAD Databases
August 7, 2007: Pharmaceutical Affairs and Food Sanitation Council (PAFSC)
discloses embarrassing error in the completed safety survey, the Tamiflu saga to be continued ... previous comments | Chugai products in JAD Databases
August 6, 2008: JKS News: MHLW
started to inoculate selected medical practitioners as first step against pandemic outbreak of new influenza strains... Consulting services | Vaccines in Japan report preview
August 5, 2008: JKS News: The 64th Japanese regulatory authorities' periodic information meeting "The 18th ICH Immediate Briefings" held in Tokyo ... JKS reports on previous meetings |
JKS technical documents
August 4, 2008: JKS News: The unlisted Kowa KK
- a diversified business group, active in both R&D and OTC pharmaceuticals, acquires US-based specialty drugs ProEthic Pharmaceuticals Inc.   to support the North America launch of Livalo (pitavastatin) ...
Kowa products in JAD Databases |
statins in Japan reports
August 4, 2008: JKS News: MHLW's
designates 2 new orphan products (ODD No. 213 and ODD No. 214) ...
orphan drug details in JAD Databases | report preview
August 3, 2008: JKS News: PM Fukuda   reshuffles the Cabinet, appoints the MP and ex-Environment Minister Dr. Ichiro Kamoshita   - a physician, as Senior Vice-Minister of MHLW to carry the healthcare reforms
August 1, 2008: JKS News: MHLW
held hearing on 2007 "New Pharmaceutical Industry Vision and Action Plan for its Achievement", priority given to vaccine development, EFPIA, PhRMA voiced opinions ... Consulting services
July 31, 2008: JKS News: Chugai Seiyaku KK
  reports half-year earnings, sales of Tamiflu dropped by 93% ... Chugai products in JAD Databases |
related readings
July 30, 2008: JKS News: Financially-indebted but ambitious Osaka Prefectural Government   to create Japan's largest biotechnology hub based on Saito Life Science Park
  , Osaka University Faculty of Medicine   and historic downtown Doshomachi  pharma companies HQ area
June 29, 2008: JKS News: While Cultural Affairs Agency   found "stress" to be most recognizable (98.5%) foreign word in Japan, indiscriminate knife attacks by undiagnosed and untreated psychotic persons become a weekly occurrence ... psychiatry report preview
July 28, 2008: JKS News: Embattled Tanabe-Mitsubishi Seiyaku KK recovered
from tainted blood products Hepatitis C disaster to expand in 2008 to the 4th largest share (4.9%) of prescription drugs sales in Japan, displacing both Pfizer and Chugai ...
TM product details in JAD Databases |
related reading
July 25, 2008: JKS News: Mr. Y. Hasegawa
  - the Vice-Chairman of Keizai Doyukai (Japan Association of Corporate Executives)
  and President of Takeda Yakuhin   introduces the JACE vision for "Creating a New Style of Japanese Management" and postulates that the unique Takeda's management style and corporate culture is the only barrier against foreign acquirers ... related reading
July 24, 2008: JKS News: MHLW
made public the 2008 draft version of "Medical Devices Industry Vision" mapping plans for the next 5 years, now soliciting public opinions ...
Medical devices / IVD consulting
July 23, 2008: JKS News: Otsuka Holding Group
  a diversified 100-member conglomerate to acquire all Itoham Life Science KK properties
  including American Peptide Co.
  to expand its ingredients and API capacities ...
Otsuka products in JAD Databases | related report preview
July 22, 2008: MHLW
 
announces coming release of "Five Peace-of-Mind Plans" for overhaul of social security system, possibly ministry's administrative restructuring ...
July 22, 2008: Momenta Pharmaceuticals
  successfully submitted in US the first generic version of Copaxone (Glatiramer acetate), an yet unapproved in Japan product indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS) ... related report preview
July 18, 2008: JKS News: MHLW
released for qualified public comments the Step 2 draft of ICH Harmonised Tripartite Guideline "Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" ... Japanese guidelines consulting
July 17, 2008: JKS News: Kinetic Concepts Inc.
  announced that by end of June has completed in Japan the Phase II trial required for approval of its negative pressure wound therapy (NPWT) technique ...
medical device consulting
July 16, 2007: JKS News: The Japan Medical Association
  published a full-page petition
  in national newspapers soliciting Japanese citizens to protest 220 billion Yen health insurance cost-reduction plan of the Government
July 16, 2008: MHLW
approved 23 new products, including anti-cancer drugs in summer round of approval ... details in JAD Databases | related report preview
July 15, 2008: JKS News: PMDA
starts soliciting public comments in relation to the Pharmacopoeia Discussion Group (PDG) international harmonization of the Japanese Pharmacopoeia XV   ... Information Meetings reports
July 14, 2008: JKS News: Arinobu Tojo
  , a researcher at the Molecular Therapy, Advanced Clinical Research Center, Institute of Medical Science, University of Tokyo
  admits falsifying IRB approval, retracts the published in May 2008 in Ferrata Storti Foundation medical journal Haematologica
  article; MHLW to revise the clinical research and tissue handling guidelines ... Japanese guideline consulting |
Laws
July 12, 2008: MHLW
announced positively concluded 1-year 10,000 person Tamiflu safety survey ... previous comments | Chugai products in JAD Databases
July 11, 2008: JKS News: The 63rd Japanese regulatory authorities' periodic information meeting "Drugs and Medical Devices Production Monitoring - Emphasis on GMP, QSM, Counterfeiting and Narcotics" held in Tokyo ... JKS reports on previous meetings |
JKS
technical documents
July 11, 2008: JKS News: MHLW
appoints Mr. Yasuyuki Takai (former Head of the Public Affairs Office to the Cabinet Secretariat) as new Director-General of PFSB, promotes Mr. Kazuhiko Mori to Head of the Safety Division ...
Japanese
Government |
Presentation by PFSB officials
July 10, 2008: JKS News: Sekisui Medical KK
  , a subsidiary of Sekisui Chemical KK conglomerate acquires US-based XenoTech
  to expand capabilities for "evaluating drug candidates as substrates, inhibitors and inducers of Cytochrome P450 enzymes" ... related pre-clinical research regulations |
Sekisui in JAD Databases
July 8, 2008: JKS News: Regardless of sensational claims of Indian tabloids for Pfizer's counterbid, Daiichi-Sankyo KK   remains the only contender for Ranbaxy Laboratories Ltd (RLL)
after expiration of the legal bid-logging period
July 7, 2008: JKS News: MHLW
released survey results for dementia and juvenile dementia prevalence...
details in JAD Databases |
related services
July 4, 2008: JKS News: After spinning-off its Aichi Central Research Laboratories and world-auctioning its equipment
  Pfizer KK became 3rd largest stockholder in RaQualia Souyaku KK ...
extended Pfizer news |
Pfizer in JAD Databases
July 3, 2008: JKS News: Kyoto University
 
established iPS Academia Japan KK to "prevent some groups or companies from monopolizing the iPS technology", the lead researcher
  says meaningful therapeutics 30 years away
July 2, 2008: JKS News: BioForum / BioExpo, Interphex Japan 2008
  opened in Tokyo, most of the key domestic and foreign pharmaceutical companies conspicuously absent from 650 exhibitors
July 2, 2008: JKS News: Researchers at Duke University Medical Center
  published "MicroRNAs expressed by herpes simplex virus 1 during latent infection regulate viral mRNAs" - with a potential new approach for treatment of herpetic infections ...related JKS research | report preview |
market research services
July 1, 2008: JKS News: MHLW
revamps the web site, introduces new logo
  , content for mobile phone users
July 1, 2008: JKS News: The introduction of age-verification TASPO card
  for vending machine cigarettes purchase projected to increase the demand for OTC smoking-cessation aids... relevant products in JAD Databases
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